Panacea Pharma Projects Limited

Clinical trial pharmacovigilance services
Medical writing services
Personal coaching
Pharmacovigilance consultancy
Physician / medic services
PSUR writing services
Quality management consultancy
QPPV consultancy
Regulatory affairs consultancy
Signal detection consultancy
Training services
+44 1624 672 777
info@panacea.im
www.panacea.im

Panacea is a leading provider of pharmacovigilance, regulatory affairs, and quality services. Our flexible and responsive technical teams help our clients in a variety of ways; whether it is a one-off task, a fixed-term project or a continuous relationship.

Our services include:

 Pharmacovigilance

Full and ad hoc services including:

  • UK & EU QPPV services
  • Local PV services (EU / worldwide)
  • Risk Management Plans (RMPs)
  • Periodic Safety Update Reports (PSURs)
  • Case processing
  • Signal detection and management
  • Fully validated pharmacovigilance database
  • Global literature monitoring

 Regulatory Affairs

  • MA applications and lifecycle management
  • Product Information preparation and maintenance
  • Quality Overall Summaries
  • Clinical and Non-clinical Overviews
  • XEVMPD maintenance

 Quality

  • Quality Management System (QMS) review and gap analysis
  • SOP reviews, writing & implementation
  • Maintenance and management of Pharmacovigilance Agreements / SDEAs
  • Inspection preparations / training
  • Creation and maintenance of Pharmacovigilance System Master Files (PSMFs)
  • Pharmacovigilance training